PVR-100/VASOGRAM
FDA 510(k) clearance K990123 · decided 1999-04-12
Clearance details
- K-number
- K990123
- Device name
- PVR-100/VASOGRAM
- Applicant
- Vasocor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-01-13
- Decision date
- 1999-04-12
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- JOM
- Device class
- 2
- Regulation number
- 870.2780
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.